Drug intelligence / Profile preview

enekinragene inzadenovec

Development stage
Phase 2
Lead developer
Pacira BioSciences
Modality
Gene Therapies, Recombinant Proteins and Enzymes
Administration
Intraarticular
01

Overview

Enekinragene inzadenovec is a novel, non-opioid, locally administered gene therapy designed to treat osteoarthritis of the knee. It utilizes a proprietary high-capacity adenovirus vector platform to deliver genetic material that stimulates the expression of interleukin-1 receptor antagonist (IL‑1Ra), an anti-inflammatory protein. By increasing IL‑1Ra production in joint tissues, the therapy aims to counteract chronic inflammation and slow disease progression in osteoarthritis. Developed by Flexion Therapeutics (a subsidiary of Pacira BioSciences) and originally discovered at Baylor College of Medicine, enekinragene inzadenovec has demonstrated sustained improvements in knee pain, stiffness, and function for up to two years following a single intra-articular injection in clinical studies. The drug has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US FDA and Advanced Therapy Medicinal Product (ATMP) status from the European Medicines Agency[1][2][3][4][5][7].

Brand names
PCRX-201PCRX201PCRX 201
Other names
Humantakinogene hadenovec
02

Targets

IL-1R (Interleukin-1 receptor type 1 (IL-1R1))IL1RN (Interleukin-1 receptor antagonist)

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